Bypass grafting method which uses a number of balloon catheters to inhibit blood flow to an anastomosis site

ABSTRACT

A method of securing an end portion of a graft to a blood vessel of a patient&#39;s circulatory system during a bypass grafting procedure includes the step of inhibiting blood flow to a region of the circulatory system by inflating a number of balloons within the circulatory system, wherein a segment of the blood vessel is located in the blood flow inhibited region. The method further includes the step of creating an arteriotomy in a sidewall of the segment of the blood vessel while the number of balloons are inflated within the circulatory system. Additionally, the method includes the step of anastomosing the end portion of the graft to the segment of the blood vessel during the blood flow inhibiting step.

This application is a continuation of application Ser. No. 09/073,336,filed May 5, 1998, which in turn is a continuation of application Ser.No. 08/702,742, filed Aug. 23, 1996, now U.S. Pat. No. 5,749,375, whichin turn is a continuation of application Ser. No. 08/391,960, filed Feb.21, 1995, now U.S. Pat. No. 5,571,167, which is in turn a continuationof application Ser. No. 08/138,912, filed Oct. 18, 1993, now U.S. Pat.No. 5,456,712, which is in turn a division of application Ser. No.08/056,371, filed on May 3, 1993, now U.S. Pat. No. 5,304,220, which inturn is a continuation-in-part of application Ser. No. 07/725,597, filedon Jul. 3, 1991, now U.S. Pat. No. 5,211,683.

BACKGROUND OF THE INVENTION

The present invention relates generally to a method for improving bloodflow in the body of a patient and more particularly concerns a bypassgrafting method which uses a number of balloon catheters to inhibitblood flow to an anastomosis site.

Treatment of vascular disease in which the lumen of a blood vessel issignificantly narrowed or occluded by atherosclerosis includes surgicaland endovascular methods. Conventional surgical methods includeobtaining access to a blood vessel via one or more surgical incisionsand either removing the blockage by performing an endarterectomy orbypassing the blockage by placing a bypass graft which has a generallycylindrical shape. Endovascular methods include obtaining access to ablood vessel with a catheter and improving blood flow therein byperforming an athrectomy, atherolysis, or balloon and laser angioplastywith or without endovascular stent placement. In general, the preferredtreatment of severe stenosis or occlusion of a long vessel segment hasbeen surgical bypass grafting.

Although conventional surgical bypass grafting is an accepted procedure,it presents substantial morbidity and mortality risks. Also, not allpatients are acceptable candidates for the above surgical procedure dueto advanced age and preexisting medical conditions. Moreover,conventional surgical bypass grafting is an invasive procedure which mayrequire extended hospitalization due to postoperative recovery. Inaddition, the above surgical procedure may involve substantial financialcosts to patients, hospitals and society in general. Further, incisionsmade during the above surgical procedure may cause significantcosmetically unattractive scarring which is undesirable to manypatients.

SUMMARY OF THE INVENTION

One embodiment of the present invention involves a method of implantinga graft prosthesis in the body of a patient to bypass a segment of ablood vessel. The method includes the steps of (1) making an incision inthe body, (2) positioning a graft so that one end of the graft islocated substantially adjacent the blood vessel at a site upstream ofthe segment and a second end of the graft is located substantiallyadjacent the blood vessel at a site downstream of the segment, whereinthe positioning step includes the step of placing the graft into thebody through the incision, and further wherein the positioning step isperformed while the upstream site is covered by a substantially intactportion of the epidermis of the body, (3) isolating a region of the areawithin the blood vessel substantially adjacent the upstream site fromfluid communication with the rest of the area within the blood vessel,wherein the upstream isolating step is performed while the upstream siteis covered by the substantially intact portion of the epidermis of thebody, (4) making an arteriotomy in a sidewall of the blood vesselsubstantially adjacent the upstream site to create a communicatingaperture between the upstream isolated region and an area outside of theblood vessel, wherein the upstream arteriotomy making step is performedwhile the upstream site is covered by the substantially intact portionof the epidermis of the body, (5) forming an anastomosis between the oneend of the graft and the blood vessel substantially adjacent theupstream site, wherein the upstream anastomosis forming step isperformed while the upstream site is covered by the substantially intactportion of the epidermis of the body, and further wherein the upstreamanastomosis forming step includes the step of suturing the one end ofthe graft to the blood vessel, (6) isolating a region of the area withinthe blood vessel substantially adjacent the downstream site from fluidcommunication with the rest of the area in the blood vessel, (7) makingan arteriotomy in the sidewall of the blood vessel substantiallyadjacent the downstream site to create a communicating aperture betweenthe downstream isolated region and the area outside of the blood vessel,and (8) forming an anastomosis between the second end of the graft andthe blood vessel substantially adjacent the downstream site.

Another embodiment of the present invention involves a method forimplanting an end portion of a graft within the body of a patient duringa bypass grafting procedure. The method includes the steps of (1) makingan incision in the body at a first location, (2) isolating a region ofthe area within a blood vessel of the body substantially adjacent asecond location from fluid communication with the rest of the areawithin the blood vessel, wherein the first location is remote from thesecond location, and further wherein the isolating step is performedwhile the second location is covered by a substantially intact portionof the epidermis of the body, (3) making an arteriotomy in the sidewallof the blood vessel substantially adjacent the second location to createa communicating aperture between the isolated region and the outside ofthe blood vessel, wherein the arteriotomy making step is performed whilethe second location is covered by the substantially intact portion ofthe epidermis of the body, (4) advancing the end portion of the graftthrough the incision to the second location, wherein the advancing stepis performed while the second location is covered by the substantiallyintact portion of the epidermis of the body, and (5) forming ananastomosis between the end portion of the graft and the blood vesselsubstantially adjacent the second location, wherein the anastomosisforming step is performed while the second location is covered by thesubstantially intact portion of the epidermis of the body, and furtherwherein the anastomosis forming step includes the step of suturing theend portion of the graft to the blood vessel.

Still another embodiment of the present invention involves a graft whichis securable to a sidewall of a blood vessel having an arteriotomydefined therein. The graft includes a body portion, and a flanged endportion attached to the body portion, the flanged end portion beingpositionable substantially adjacent a portion of the sidewall of theblood vessel which substantially surrounds the arteriotomy.

Yet another embodiment of the present invention involves a graft andstent assembly which is securable to a sidewall of a blood vessel havingan arteriotomy defined therein. The graft and stent assembly includes agraft having an end portion which is positionable within the bloodvessel and substantially adjacent a portion of the sidewall of the bloodvessel which substantially surrounds the arteriotomy. The graft andstent assembly further includes a stent positionable within the bloodvessel and in contact with the end portion of the graft so as to securethe end portion of the graft between the sidewall of the blood vesseland the stent.

One object of the present invention is to provide an improved method forimplanting a graft prosthesis in the body of a patient.

Another object of the present invention is to provide an improved methodfor implanting an end portion of a graft within the body of a patient.

Still another object of the present invention is to provide a method ofimplanting a graft prosthesis in the body of a patient which is lessinvasive relative to conventional surgical bypass grafting procedures.

Yet another object of the present invention is to provide a method ofimplanting a graft prosthesis in the body of a patient which obviates atleast one surgical incision (e.g. the abdominal surgical incision) ascompared to conventional surgical bypass grafting procedures.

Still another object of the present invention is to provide a method ofimplanting a graft prosthesis in the body of a patient which has lowmorbidity and mortality risk to patients.

Yet another object of the present invention is to provide a method ofimplanting a graft prosthesis in the body of a patient which can beperformed on patients whom are elderly or have poor preexisting medicalconditions.

Still another object of the present invention is to provide a method ofimplanting a graft prosthesis in the body of a patient which requiresrelatively less financial costs to patients, hospitals and society ingeneral as compared to conventional surgical bypass grafting techniques.

Yet another object of the present invention is to provide an improvedgraft prosthesis.

Still another object of the present invention is to provide an improvedgraft and stent assembly.

Another object of the present invention is to provide a graft which canbe conveniently secured to a blood vessel.

Yet another object of the present invention is to provide a graft andstent assembly which allows the graft to be conveniently secured to ablood vessel.

Yet still another object of the present invention is to provide a graftwhich is easy to implant in the body of a patient.

Still another object of the present invention is to provide a graft andstent assembly which is easy to implant in the body of a patient.

Another object of the present invention is to provide a graft whichfunctions well after it is implanted in the body of a patient.

Yet another object of the present invention is to provide a graft andstent assembly which functions well after it is implanted in the body ofa patient.

Other objects and benefits of the present invention can be discernedfrom the following description and accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a fragmentary front elevational view of a human body showing ablood vessel which includes the aorta, the right common iliac artery,the right common femoral artery and the left common femoral arterywherein a segment of the blood vessel is occluded. FIG. 1 also shows aportion of each inguinal ligament of the human body.

FIG. 2 is an enlarged fragmentary view of the human body and bloodvessel of FIG. 1.

FIG. 3 shows the human body and blood vessel of FIG. 2 with aballoon-tip catheter positioned within the blood vessel wherein theballoon is inflated in accordance with the preferred method of thepresent invention.

FIG. 4 is a view similar to FIG. 3 but showing a second balloon-tipcatheter positioned within the blood vessel wherein the second balloonis inflated in accordance with the preferred method of the presentinvention.

FIG. 5 is a view similar to FIG. 4 but showing the blood vessel inphantom except for a portion thereof that is exposed through a gapingsurgical incision. Also shown exposed through the surgical incision inFIG. 5 is a portion of the right inguinal ligament.

FIG. 6 is a view similar to FIG. 5 but showing another portion of theblood vessel, including the aorta, exposed for clarity of description.Moreover, in FIG. 6, a laparoscope (depicted schematically) is showninserted through the surgical incision in accordance with the preferredmethod of the present invention.

FIG. 7 is a view similar to FIG. 6 but showing a needle positionedwithin the laparoscope in accordance with the preferred method of thepresent invention.

FIG. 8 is a view similar to FIG. 7 but showing the needle removed fromthe laparoscope and replaced with a scissors device in accordance withthe preferred method of the present invention.

FIG. 9A is an elevational view of a graft prosthesis used in carryingout the preferred method of the present invention.

FIG. 9B is a fragmentary sectional view taken along the line 9B--9B ofFIG. 9A as viewed in the direction of the arrows.

FIG. 9C is a fragmentary perspective view of the graft prosthesis ofFIG. 9A showing its outwardly extending flanged end portion.

FIG. 9D is another fragmentary perspective view of the graft prosthesisof FIG. 9A showing its outwardly extending flanged end portion.

FIG. 9E is a view similar to FIG. 9C but showing a plurality of springs,in phantom, integrally positioned within the outwardly extending flangedend portion, in addition to, a portion of the sidewalls of the graftprosthesis of FIG. 9A.

FIG. 9F is an elevational view of one of the plurality of springs ofFIG. 9E.

FIG. 9G is an elevational view of another of the plurality of springs ofFIG. 9E.

FIG. 9H is an elevational view of yet another of the plurality ofsprings of FIG. 9E.

FIG. 9I is an elevational view of still another of the plurality ofsprings of FIG. 9E.

FIG. 10A is an elevational view of the graft prosthesis of FIG. 9Awherein the graft prosthesis is in a rolled configuration.

FIG. 10B is a cross-sectional view taken along the line 10B--10B of FIG.10A as viewed in the direction of the arrows.

FIG. 11A is an elevational view of the laparoscope of FIG. 6. Moreover,FIG. 11A shows the graft prosthesis of FIG. 10A, positioned within thelaparoscope in accordance with the method of the present invention. FIG.11A further shows a plunger, used in carrying out the preferred methodof the present invention, partially positioned within the laparoscope inaccordance with the preferred method of the present invention.

FIG. 11B is a cross-sectional view taken along the line 11B--11B of FIG.11A as viewed in the direction of the arrows.

FIG. 12 is a view similar to FIG. 8 but showing the scissors deviceremoved from the laparoscope and replaced with the graft prosthesis andplunger of FIG. 11A in accordance with the preferred method of thepresent invention.

FIG. 13 is a view similar to FIG. 12 but showing the graft prosthesisbeing advanced out the distal end of the laparoscope in accordance withthe preferred method of the present invention.

FIG. 14 is a view similar to FIG. 13 but showing the graft prosthesisbeing further advanced out the distal end of the laparoscope inaccordance with the preferred method of the present invention.

FIG. 15 is a view similar to FIG. 14 but showing the graft prosthesisbeing yet further advanced out the distal end of the laparoscope inaccordance with the preferred method of the present invention.

FIG. 16 is a view similar to FIG. 15 but showing the laparoscope removedfrom the surgical incision and showing the graft prosthesis after it hadreverted back to its prerolled configuration in accordance with thepreferred method of the present invention.

FIG. 17 is a view similar to FIG. 16 but showing a third balloon-tipcatheter having a balloon thereon and further having an expandablestent, in its unexpanded state, positioned over the balloon, advanced toa position within the blood vessel in accordance with the preferredmethod of the present invention.

FIG. 18 is a view similar to FIG. 17 but showing the balloon of thethird balloon-tip catheter inflated so as to expand the stent in to itsexpanded configuration in accordance with the preferred method of thepresent invention.

FIG. 19A is a view similar to FIG. 18 but showing the third balloon-tipcatheter removed from the blood vessel and showing the stent expanded toform an anastomosis between one end of the graft prosthesis and theblood vessel in accordance with the preferred method of the presentinvention.

FIG. 19B is an enlarged schematic side elevational view showing a numberof sutures tied to the sidewall of the blood vessel so as to secure theend portion of the graft and the stent thereto as a possible additionalprocedure in order to further ensure the integrity of the anastomosis ofFIG. 19A.

FIG. 19C is a cross-sectional view taken along the line 19C--19C of FIG.19B as viewed in the direction of the arrows.

FIG. 19D is a view similar to FIG. 19A but showing a laparoscope(depicted schematically) inserted through an incision in the epidermisof the body and into the peritoneal cavity, and further showing agrasper holding a curved needle with an end of a suture attached theretowherein the distal end of the grasper is positioned at the upstreamsite.

FIG. 19E is an enlarged schematic side elevational view showing a numberof sutures tied to the sidewall of the blood vessel so as to secure theend portion of the graft thereto (without the use of the stent), whereinthe end portion of the graft is positioned within the upstream isolatedregion, as an alternative procedure in forming an anastomosis betweenthe end portion of the graft and the blood vessel.

FIG. 19F is a cross-sectional view taken along the line 19F--19F of FIG.19E as viewed in the direction of the arrows.

FIG. 19G is an enlarged schematic side elevational view showing a numberof sutures tied to the sidewall of the blood vessel so as to secure theend portion of the graft thereto (without the use of the stent), whereinthe end portion of the graft is positioned outside of the upstreamisolated region, as another alternative procedure in forming ananastomosis between the end portion of the graft and the blood vessel.

FIG. 19H is a cross-sectional view taken along the line 19H--19H of FIG.19G as viewed in the direction of the arrows.

FIG. 20A is an enlarged side elevational view showing the anastomosis ofFIG. 19A.

FIG. 20B is a cross-sectional view taken along the line 20B--20B of FIG.20A as viewed in the direction of the arrows.

FIG. 20C is a cross-sectional view taken along the line 20C--20C of FIG.20A as viewed in the direction of the arrows.

FIG. 21 is a view similar to FIG. 19A but showing a pair of clampspositioned on the blood vessel in accordance with the preferred methodof the present invention.

FIG. 22 is a view similar to FIG. 21 but showing an arteriotomy formedin the sidewall of the blood vessel in accordance with the preferredmethod of the present invention.

FIG. 23 is a view similar to FIG. 22 but showing an anastomosis formedbetween the other end the graft prosthesis and the blood vessel inaccordance with the preferred method of the present invention.

FIG. 24 is a view similar to FIG. 23 but showing the first balloon-tipcatheter and the second balloon-tip catheter removed from the bloodvessel in accordance with the preferred method of the present invention.

DESCRIPTION OF THE PREFERRED EMBODIMENT

For the purposes of promoting an understanding of the principles of theinvention, reference will now be made to the embodiments and methodsillustrated in the drawings and specific language will be used todescribe the same. It will nevertheless be understood that no limitationof the scope of the invention is thereby intended, such alterations andfurther modifications in the illustrated devices and methods, and suchfurther applications of the principles of the invention as illustratedtherein being contemplated as would normally occur to one skilled in theart to which the invention relates.

Referring now to the drawings, FIG. 1shows a portion of a human body,generally designated by the reference numeral 10, with an artery, thecommon iliac artery 12, having an occluded segment, generally designatedby the reference numeral 14. Human body 10 is further shown having otherarteries, in particular, aorta 16, right common femoral artery 18, leftcommon femoral artery 30 and renal arteries 20. In addition, human body10 includes a right inguinal ligament 19 and a left inguinal ligament29. Human body 10 also includes an epidermis 13 (see e.g. FIG. 6). Thepreferred method disclosed herein describes the implantation of a graftto couple aorta 16 to right common femoral artery 18 thereby bypassingoccluded segment 14. FIG. 2 shows an enlarged view of aorta 16, rightcommon iliac artery 12, occluded segment 14, right common femoral artery18, left common femoral artery 30, renal arteries 20 and right inguinalligament 19. In FIGS. 1 and 2, a blood vessel is shown, generallydesignated by the reference numeral 11, which includes aorta 16, rightcommon iliac artery 12, right common femoral artery 18 and left commonfemoral artery 30. Blood vessel 11, when not occluded, conveys bloodfrom a point C within aorta 16 to a point D within right common femoralartery 18 (see FIGS. 1-2). However, due to the presence of occludedsegment 14, blood is substantially totally precluded from being conveyedfrom point C within aorta 16 to point D within right common femoralartery 18 via the direct route of right common iliac artery 12. Whilethe inventive method will hereinafter be described with regard to asubstantially totally occluded segment of a blood vessel of a patient,it will be understood to one skilled in the art that the inventivemethod is equally effective for bypass of a partially occluded segmentof a blood vessel. In addition, the inventive method is also useful forbypass of an aneurysmal segment of a blood vessel.

Referring now to FIGS. 3-24, successive steps according to the preferredmethod of the present invention are depicted of the implantation of agraft prosthesis of the present invention to couple aorta 16 to rightcommon femoral artery 18 thereby bypassing occluded segment 14 of bloodvessel 11.

One step of the preferred method of the present invention comprisesisolating a region of the area within the blood vessel 11, located neara site 21 (see FIG. 4) upstream of occluded segment 14, from fluidcommunication with the rest of the area within the blood vessel. Therealso exists a site 31 which is located downstream of occluded segment 14(see FIG. 4). Upstream site 21is located substantially adjacent theblood vessel 11 and designates a working area where the distal end ofmedical instruments and various medical devices may be positioned duringthe process of securing one end of a graft to the blood vessel. Upstreamsite 21 is located near blood vessel 11 so as to allow such distal endof medical instruments and medical devices to be appropriatelymanipulated at upstream site 21 to thereby successfully secure the oneend of the graft to the blood vessel. Downstream site 31 is locatedsubstantially adjacent the blood vessel 11 and also designates a workingarea where the distal end of medical instruments, physician's hands andvarious medical devices may be positioned during the process of securinga second end of the graft to the blood vessel. Downstream site 31 isalso located near blood vessel 11 so as to allow such distal end ofmedical instruments, physician's hands and medical devices to beappropriately manipulated at downstream site 31 to thereby successfullysecure the second end of the graft to the blood vessel.

Referring now to FIG. 3, a balloon-tip catheter 22 having a balloon 24thereon is percutaneously inserted into blood vessel 11 via the right orleft axillary artery (not shown). This step may be accomplished usingstandard catherization techniques. The distal end of catheter 22 is thenadvanced into aorta 16 until balloon 24 is positioned distal to renalarteries 20 as shown in FIG. 3. Balloon 24 is then inflated to andmaintained at a size such that fluid communication is substantiallyterminated in aorta 16 between the portion of blood vessel 11 proximalto balloon 24 and the portion of blood vessel 11 distal to balloon 24.Since conventional balloon-tip catheters may not have a balloon thereonthat possess the characteristics necessary to terminate fluidcommunication in the aorta as described above, modification may bereadily made to an existing design of a conventional balloon-tipcatheter to achieve the above desired results. One such modificationwould include providing a balloon on the catheter with is inflatable toan outer diameter which is larger than the inner diameter of the aorta.Another such modification would include providing a coarse texturedouter surface to the balloon of the catheter. The above modificationwould provide increased frictional resistance between the inflatedballoon and the sidewall of the blood vessel when force is applied tothe balloon in the axial direction thereof. A balloon-tip catheterhaving a conventional design is available through Medi-tech,Incorporated of Watertown, Mass., as Order No. 17-207 (Description:OBW/40/8/2/100).

Referring now to FIG. 4, a balloon-tip catheter 26 having a balloon 28thereon and an open lumen defined therein is percutaneously insertedinto blood vessel 11 via the left common femoral artery 30. This stepmay be accomplished using standard catherization techniques. The distalend of the catheter 26 is then advanced into aorta 16 until balloon 28is positioned proximal to the aortic bifurcation. Balloon 28 is theninflated to and maintained at a size such that fluid communication issubstantially terminated in aorta 16 between the portion of blood vessel11 proximal to balloon 28 and the portion of blood vessel 11 distal toballoon 28. Since conventional balloon-tip catheters may not have aballoon thereon that possess the characteristics necessary to terminatefluid communication in the aorta as described above, modificationsimilar to that described with respect to catheter 22 may need to bemade to catheter 26. In addition, further modification may need to bemade to catheter 26 since a conventional balloon-tip catheter may nothave an open central lumen defined therein which possesses a diameterlarge enough for the advancement therethrough of a compressed stentmounted on a balloon of another balloon-tip catheter as will be requiredby the preferred method of the present invention (see FIG. 17). Suchfurther modification would be to create an open central lumen incatheter 26 that possesses a diameter larger than the outer diameter ofthe compressed stent which is mounted on the balloon of the balloon-tipcatheter as referred to above. Due to the increased size requirements ofcatheter 26 as alluded to above, a surgical cut-down may need to beperformed in order to expose left common femoral artery 30. Suchexposure would facilitate both placement of catheter 26 into bloodvessel 11 and repair of such blood vessel following subsequent removalof such catheter therefrom.

Temporary occlusion of the blood flow in the inferior mesenteric artery(not shown) by laparoscopic procedures may need to be performed in orderto prevent the flow of blood from the inferior mesenteric artery intoaorta 16 due to placement of inflated balloons 24 and 28 as discussedabove.

The region bound by balloon 24 of catheter 22 and balloon 28 of catheter26 and the sidewall of blood vessel 11 contained therebetween defines aregion 40 of the area within blood vessel 11, located near site 21upstream of occluded segment 14, which is substantially isolated fromfluid communication with the rest of the area within blood vessel 11.

Alternatively, the step of isolating the region of the area within bloodvessel 11, located near upstream site 21, from fluid communication withthe rest of the area within the blood vessel may be accomplished bylaparoscopically placing a first clamp around the blood vessel 11 at thelocation where balloon 24 of the balloon-tip catheter 22 was describedas having been inflated and also laparoscopically placing a second clamparound the blood vessel 11 at the location where balloon 28 of theballoon-tip catheter 26 was described as having been inflated.

Another step according to the method of the present invention comprisesmaking an arteriotomy in the sidewall of blood vessel 11, near upstreamsite 21, to create a communicating aperture between upstream isolatedregion 40 and the outside of blood vessel 11.

Referring now to FIG. 5, right common femoral artery 18 and rightinguinal ligament 19 are exposed via a surgical incision 17. Suchexposure is accomplished using standard surgical techniques.

Insufflation of the peritoneal cavity is then performed using standardtechniques associated with laparoscopy. A laparoscope 37 (see FIG. 6),having an open central lumen (i.e. a working channel) defined therein,is then inserted into human body 10 through the opening between rightcommon femoral artery 18 and right inguinal ligament 19. Laparoscope 37may additionally include a fiber optic illumination device and atelescope for viewing. A tilt table may be used with the patient (i.e.human body 10) positioned thereon in order to maneuver the patient'sabdominal contents away from the laparoscope insertion site and the areanear upstream site 21. Laparoscope 37 is then advanced toward upstreamsite 21 until its distal end is positioned thereat as shown in FIG. 6.One or more additional laparoscopes and associated laparoscopicoperating instruments may be employed using standard laparoscopictechniques to assist in the above positioning via direct visualization,tissue retraction and tissue dissection. One laparoscope which may beused in carrying out the preferred method of the present invention isavailable through Karl Storz Endoscopy-America, Incorporated of CulverCity, Calif. as Catalog No. 26075A. Modification may be readily made tolaparoscope 37, such as rounding the distal edge thereof, in order toreduce the possibility of tissue trauma as a result of advancement oflaparoscope 37 within human body 10. A book which discloses variousstandard laparoscopic techniques and standard associated laparoscopicoperating instruments is entitled "Laparoscopy for Surgeons," authoredby Barry A. Salky, M.D., published by Igaku-Shoin Medical Publishers,Inc. of New York, N.Y., U.S.A. (1990), and the pertinent part of thedisclosure of which is herein incorporated by reference.

Referring now to FIG. 7, a puncture needle 39 is advanced through theopen central lumen of laparoscope 37 until its distal end exits thelaparoscope. Thereafter, needle 39 is manipulated to penetrate throughthe sidewall of blood vessel 11 to the inside thereof, thus creating apuncture in the blood vessel. Needle 39 is then withdrawn and a scissorsdevice 41 is advanced through the open central lumen of laparoscope 37until its distal end exits the laparoscope (see FIG. 8). The scissorsdevice is then manipulated to enlarge the puncture in the sidewall ofthe blood vessel. Scissors device 41 is then withdrawn from laparoscope37. One puncture needle which may be used in carrying out the preferredmethod of the present invention is available through Karl StorzEndoscopy-America, Incorporated of Culver City, Calif., as Catalog No.26178R. Additionally, one scissors device which may be used in carryingout the method of the present invention is available through Karl StorzEndoscopy-America, Incorporated of Culver City, Calif., as Catalog No.26178PS.

It should be noted that if upstream isolated region 40 was notsubstantially isolated from fluid communication with the rest of thearea within the blood vessel, the act of making an arteriotomy in thesidewall of blood vessel 11 near upstream site 21 would causesignificant blood leakage out of blood vessel 11 and such blood leakagemay be fatal to the patient.

According to another step of the method of the present invention, agraft prosthesis is positioned so that one end of the graft is locatedsubstantially adjacent blood vessel 11 at downstream site 21 and theother end of the graft prosthesis is located substantially adjacentblood vessel 11 at downstream site 31. The above positioning stepincludes the step of advancing the graft prosthesis within the humanbody 10 with a medical instrument.

One type of graft prosthesis which may be used is a graft, generallydesignated by the reference numeral 60 and shown n FIGS. 9A-9E. Graft 60includes a body portion 61 having a length slightly larger than thedistance between upstream site 21 and downstream site 31. Graft 60 hasan outwardly extending flanged end portion 62 as shown in FIGS. 9A, 9C,9D and 9E. End portion 62 is resiliently maintained outwardly extendingby four springs 64A-64D as shown in FIGS. 9B and 9E-9I. In their relaxedstate, springs 64A-64D maintain end portion 62 within a plane P1 asshown in FIG. 9A. It should be noted that a number of springs other thanfour may be used, if desired, to maintain end portion 62 outwardlyextending as previously shown and described. Graft 60 further includes asecond end portion 63 having a design similar to that of a conventionalprosthetic graft as shown in FIG. 9A. Graft 60 is preferably made ofsynthetic fibers. By way of example, graft 60 can be made from thematerial sold under the trademark Dacron by E.I. du Pont de Nemours &Co., Inc. of Wilmington, Del. Body portion 61 and end portion 62 areintegrally formed together with springs 64A-64D maintained integrallywithin the end portion 62 and a portion of the sidewalls of body portion61 as shown in FIGS. 9B and 9E. Graft 60 maintains its shape as shown inFIGS. 9A-9E absent application of external forces thereto and also graft60 will revert back to such shape upon termination of such externalforces thereto.

Graft 60 is positioned within the open central lumen defined inlaparoscope 37. In order to achieve the above, graft 60 is preferablyrolled into a substantially cylindrical shape as shown in FIGS. 10A and10B. End portion 62 of graft 60 is manipulated to lie substantiallyparallel to body portion 61 of graft 60 while graft 60 is in its rolledconfiguration as shown in FIG. 10A. The outer diameter of graft 60, inits rolled configuration, from point W to point Y is larger than theouter diameter of the rolled graft from point Y to point Z as shown inFIG. 10A. The above is due to the angular construction of end portion 62as shown in FIG. 9A. The outer diameter of the rolled graft from point Wto point Y is slightly smaller than the inner diameter of laparoscope37. As a result, in its rolled configuration, graft 60 can be positionedwithin the open central lumen of laparoscope 37. Moreover, graft 60 canbe maintained in its rolled configuration while positioned in thecentral lumen of laparoscope 37 due to the inner diameter thereof. Graft60 is then inserted into the proximal end of the central lumen oflaparoscope 37 and advanced until its full length is entirely therein. Aplunger 82 is insertable into the central lumen of laparoscope 37 asshown in FIGS. 11A and 11B. Plunger 82 has a length sufficient to spanthe length of laparoscope 37. Plunger 82 enables an operator toselectively position graft 60 within body 10. FIGS. 11A and 12 showgraft 60 positioned in the distal portion of the central lumen oflaparoscope 37 after being advanced by plunger 82. Laparoscope 37 withgraft 60 contained therein is then advanced and manipulated such thatthe distal end of the laparoscope is advanced through the communicatingaperture near upstream site 21 and into isolated region 40. While theplunger is held stationary, laparoscope 37 is then withdrawn axiallyover plunger 82 and graft 60 in the direction of arrow 84 assequentially shown in FIGS. 13-15. This allows graft 60 in its rolledconfiguration to be delivered out the distal end of laparoscope 37. FIG.15 shows end portion 62 of graft 60 positioned within upstream isolatedregion 40 and end portion 63 of graft 60 positioned at downstream site31. Since graft 60 is no longer held in its rolled configuration by theinner diameter of the open central lumen of laparoscope 37, graft 60becomes unrolled and reverts to its prerolled configuration as shown inFIG. 16. Injection of a saline solution into graft 60, via end portion63, may be performed to facilitate the reverting of graft 60 to itsprerolled configuration. Alternatively, an additional laparoscope may beused to manipulate graft 60 to its prerolled configuration.Alternatively, a balloon-tip catheter may be advanced into graft 60 viaend portion 63 and the graft converted to its prerolled configuration byinflation and deflation of the balloon along various segments of thegraft.

Also shown in FIG. 16, end portion 62 of graft 60 is positioned withinupstream isolated region 40 near upstream site 21 and end portion 63 ofgraft 60 is positioned at downstream site 31 while body portion 61 ofgraft 60 is positioned outside of blood vessel 11. Note that end portion62 has also reverted back to its prerolled configuration so that suchend portion is outwardly extending relative to body portion 61 of graft60.

Another step according to the preferred method of the present inventionincludes forming an anastomosis between end portion 62 of graft 60 andblood vessel 11 near upstream site 21.

A balloon-tip catheter 86 having a balloon 88 thereon and further havingan expandable stent 90, in its unexpanded configuration, positioned overballoon 88 is advanced through the open central lumen of catheter 26until its distal end is located within upstream isolated region 40 nearupstream site 21 (see FIG. 17). Catheter 86 is further advanced untilballoon 88 is positioned substantially adjacent end portion 62 of graft60 as shown in FIG. 17. Balloon 88 is then inflated to expand stent 90to its expanded configuration such that end portion 62 is securedbetween stent 90 and the sidewall of blood vessel 11 near upstream site21 as shown in FIG. 18. Balloon 88 is then deflated and catheter 86 isthen removed from body 10 via the central lumen of catheter 26. FIG. 19Ashows body 10 after catheter 86 is removed therefrom. Moreover, FIGS.20A-20C show end portion 62 of graft 60 being forced into the sidewallof blood vessel 11 by stent 90 (in its expanded configuration) such thatgraft 60 is secured to blood vessel 11 near upstream site 21 at its endportion 62.

One stent which may be used, with a minor degree of modification, incarrying out the preferred method of the present invention is disclosedin U.S. Pat. No. 4,776,337 issued to Palmaz on Oct. 11, 1988, thepertinent part of the disclosure of which is herein incorporated byreference. Such modification would be to provide stent 90 with an outerdiameter (in its fully expanded configuration) that is larger than theinner diameter of blood vessel 11 near upstream site 21.

Note that stent 90 includes a plurality of intersecting bars 71 whichspan the orifice of graft 60 near end portion 62 as shown in FIG. 20B.Intersecting bars 71 which span the above orifice do not substantiallyhinder blood flow through the graft orifice as demonstrated by thetechnical article entitled "Intravascular Stents to Prevent Occlusionand Restenosis After Transluminal Angioplasty" which was published inthe Mar. 19, 1987 edition of the periodical "The New England Journal ofMedicine," the pertinent part of the disclosure of which is hereinincorporated by reference.

Further modification may be readily made to stent 90 whereby stent 90would have an opening defined in its sidewall which is of similardimensions to the orifice of graft 60 near end portion 62. Such openingwould have no intersecting bars traversing thereover. The abovemodification would allow stent 90 to be positioned within blood vessel11 near upstream site 21 wherein the above opening would besubstantially superimposed over the orifice of graft 60 near end portion62. This would allow blood to flow through the connection between bloodvessel 11 and graft 60 near upstream site 21 in an unimpeded manner.

As a possible additional procedure in order to further ensure theintegrity of the anastomosis between end portion 62 of graft 60 andblood vessel 11 near upstream site 21, a number of sutures 100 may betied to the sidewall of blood vessel 11 so as to further secure endportion 62 and stent 90 to the sidewall of blood vessel 11 asschematically shown in FIGS. 19B and 19C. This is accomplished byinserting a laparoscope 102 (which is similar to laparoscope 37) havingan open central lumen into human body 10 until its distal end is nearupstream site 21. Thereafter, a grasper 104 is advanced through thecentral lumen of laparoscope 102. The grasper 104 has in its grasp acurved needle 106 having an end of suture 100 attached thereto as shownin FIG. 19D. By manipulating the distal end of grasper 104, the needle106 and the end of suture 100 are passed through the sidewall of bloodvessel 11 and end portion 62 of graft 60 and into blood vessel 11. Withcontinued manipulation, the needle 106 and the end of suture 100 arethen brought back out of blood vessel 11. The suture 100 is then tied bystandard laparoscopic techniques. One article that refers to standardlaparoscopic techniques for tying sutures is entitled "LaparoscopicCholedocholithotomy", which was published in Volume 1, Number , 1991edition of the "Journal of Laparoendoscopic Surgery" (Mary Ann Liebert,Inc., Publishers), pages 79-82, and another article that refers tostandard laparoscopic techniques for tying sutures is entitled"Improvement in Endoscopic Hernioplasty: Transcutaneous Aquadissectionof the Musculofascial Defect and Preperitoneal Endoscopic Patch Repair",which was published in Volume 1, Number 2, 1991 edition of the "Journalof Laparoendoscopic Surgery" (Mary Ann Liebert, Inc., Publishers), pages83-90, the pertinent part of both of the above articles of which isherein incorporated by reference. A number of other sutures 100 are thentied to the sidewall of blood vessel 11 and end portion 62 of graft 60in a manner similar to that hereinbefore described so as to furthersecure end portion 62 to the sidewall of blood vessel 11 asschematically shown in FIGS. 19B and 19C. One or more additionallaparoscopes and associated laparoscopic operating instruments may beemployed using standard laparoscopic techniques to assist in the abovesuturing procedure. Of course, sutures 100 may be sewn in a conventionalrunning fashion so as to secure end portion 62 to the sidewall of bloodvessel 11. Also, end portion 62 may be sutured to the sidewall of bloodvessel 11 prior to the placement of stent 90 within blood vessel 11.

Alternatively, the step of forming an anastomosis between end portion 62of graft 60 and blood vessel 11 near upstream site 21 may beaccomplished by suturing alone (i.e. without the use of stent 90). Inparticular, once end portion 62 of graft 60 is positioned withinupstream isolated region 40 near upstream site 21 as shown in FIG. 16,end portion 62 is sutured to the sidewall of blood vessel 11 asschematically shown in FIGS. 19E and 19F. Note that in this alternativestep, end portion 62 is sutured to an interior portion of blood vessel11 as schematically shown in FIGS. 19E and 19F. Also note that endportion 62 is sutured to the sidewall of blood vessel 11 so as to bepositioned substantially adjacent a portion of the sidewall of bloodvessel 11 which substantially surrounds the arteriotomy. This isaccomplished by tying a number of sutures 110 to the sidewall of bloodvessel 11 and end portion 62 of graft 60 so as to secure end portion 62to the sidewall of blood vessel 11 as schematically shown in FIGS. 19Eand 19F. The sutures 110 shown in FIGS. 19E and 19F are applied in thesame manner as the sutures 100 shown in FIGS. 19B, 19C and 19D wereapplied as described above. Of course, sutures 110 may be sewn in aconventional running fashion so as to secure end portion 62 to thesidewall of blood vessel 11.

As a further alternative, the end portion 62 of graft 60 need not bepositioned in upstream isolated region 40 but rather end portion 62 maybe positioned adjacent the sidewall of blood vessel 11 so that thecommunicating aperture (i.e. the arteriotomy) in the sidewall of bloodvessel 11 near upstream site 21 is aligned with the central passage ofgraft 60. At this position, end portion 62 is sutured to the sidewall ofblood vessel as schematically shown in FIGS. 19G and 19H. Note that inthis further alternative step, end portion 62 is sutured to an exteriorportion of blood vessel 11 as schematically shown in FIGS. 19G and 19H.Also note that end portion 62 is sutured to the sidewall of blood vessel11 so as to be positioned substantially adjacent a portion of thesidewall of blood vessel 11 which substantially surrounds thearteriotomy. This is accomplished by tying a number of sutures 120 tothe sidewall of blood vessel 11 and end portion 62 of graft 60 so as tosecure end portion 62 to the sidewall of blood vessel 11 asschematically shown in FIGS. 19G and 19H. The sutures 120 shown in FIGS.19G and 19H are applied in the same manner as the sutures 100 shown inFIGS. 19B, 19C and 19D were applied as described above. Of course,sutures 120 may be sewn in a conventional running fashion so as tosecure end portion 62 to the sidewall of blood vessel 11.

The remainder of the preferred method of the present invention isperformed using standard surgical techniques. A book which disclosesvarious standard surgical techniques is entitled "Color Atlas ofVascular Surgery," authored by John S. P. Lumley, published by WolfeMedical Publications Ltd. of Baltimore, M.d. (1986), printed by W. S.Cowell, Ltd. of Ipswich, United Kingdom, and the pertinent part of thedisclosure of which is herein incorporated by reference. Morespecifically, another step according to the preferred method of thepresent invention comprises isolating a region 50 of the area withinblood vessel 11, located near site 31 downstream of occluded segment 14,from fluid communication with the rest of the area within the bloodvessel. Referring now to FIG. 21, a pair of surgical clamps 53 and 55are positioned on blood vessel 11, one being placed upstream of isolatedregion 50 and the other being placed downstream of isolated region 50.

Another step according to the method of the present invention comprisesmaking an arteriotomy in the sidewall of blood vessel 11, neardownstream site 31, to create a communicating aperture betweendownstream isolated region 50 and the outside of the blood vessel 11.End portion 63 of graft 60 is retracted by surgical forceps (not shown)to expose blood vessel 11 near downstream site 31 (see FIG. 22). Ascalpel puncture is then made in blood vessel 11 near downstream site 31and thereafter the puncture is extended to the appropriate length with apair of surgical scissors. FIG. 22 shows the communicating aperturedefined in the sidewall of blood vessel 11, near downstream site 31.

Another step according to the preferred method of the present inventioncomprises forming an anastomosis between end portion 63 of graft 60 andblood vessel 11 near downstream site 31. Graft 60 is then cut to anappropriate length and thereafter end portion 63 is cut an appropriateshape for attachment to blood vessel 11. End portion 63 of graft 60 isthen surgically stitched with suture 65 to blood vessel 11 neardownstream site 31 as shown in FIG. 23.

Clamps 53 and 55 are then removed from blood vessel 11, and moreover,balloons 24 and 28 are then deflated and thereafter catheters 22 and 26are removed from body 10 as shown in FIG. 24. This allows blood to flowto former upstream isolated region 40. Once blood flow reaches formerupstream isolated region 40, a flow of blood will enter graft 60 andflow therethrough to former downstream isolated region 50 therebybypassing occluded segment 14. Consequently, proper blood flow will nowexist in body 10 from point C within aorta 16 to point D within rightcommon femoral artery 18 as a result of performing the above describedmethod of bypass of occluded segment 14.

While the invention has been described in detail in the drawings andforegoing description, the same is to be considered as illustrative andnot restrictive in character, it being understood that only thepreferred embodiments and methods have been shown and described and thatall changes and modifications that come within the spirit of theinvention are desired to be protected.

For instance, it is possible that left common femoral artery 30 and leftinguinal ligament 29 could be exposed via a surgical incision similar tothat of incision 17 as hereinbefore described. Thereafter, a Y-shapedgraft could be utilized instead of graft 60 as hereinbefore disclosed.The Y-shaped graft could be advanced in a rolled configuration throughlaparoscope 37 and delivered to a position substantially adjacent bloodvessel 11 similar in manner to that hereinbefore described. Anadditional laparoscope could be inserted into human body 10 through theopening defined between left common femoral artery 30 and left inguinalligament 29 in a manner substantially similar to that hereinbeforedescribed with respect to the insertion of laparoscope 37 into humanbody 10. The additional laparoscope could be advanced toward the leftlimb of the Y-shaped graft and thereafter used to grasp such limb andpull it toward left common femoral artery 30 and subsequently out of thesurgical incision near the left common femoral artery. The end portionof the left limb of the Y-shaped graft could be cut to an appropriatelength and shape, and thereafter, an anastomosis could be made betweensuch end portion and left common femoral artery 30 similar in manner tothat hereinbefore described with regard to right common femoral artery18 and end portion 63 of graft 60.

Moreover, for example, it is possible that a graft may be utilized whichwould be similar to graft 60 hereinbefore described, however, both endportions of such graft could be similar in structure to end portion 62of graft 60. In other words, each graft end could possess an end portionthat is resiliently maintained outwardly extending relative to the bodyportion of the graft. A catheter could be placed into blood vessel 11 atright femoral artery 18 and advanced toward occluded segment 14. Priorto arriving at occluded segment 14, the distal end of the catheter couldbe manipulated and guided out of blood vessel 11 through a puncture sitelaparoscopically created in the blood vessel in a manner similar to thathereinbefore described. The catheter could then be advancedsubstantially adjacent blood vessel 11 over and past occluded segment14. One or more additional laparoscopes could assist in the aboveadvancement. The distal end of the catheter could then be manipulatedand guided to reenter blood vessel 11 at a site upstream of occludedsegment 14 through a puncture site laparoscopically created in bloodvessel 11 in a manner similar to that hereinbefore described. The grafthaving a resiliently outwardly extending end portion at each end thereofcould then be advanced in rolled configuration through the catheter anddelivered to a position substantially adjacent blood vessel 11 similarin manner to that hereinbefore described with respect to graft 60 andlaparoscope 37. The graft could have a predetermined length equal to alength slightly larger than the distance between the puncture sitelocated upstream of occluded segment 14 and the puncture site locateddownstream of occluded segment 14. As a result, the distal end portionof the graft could be positioned within blood vessel 11 at a locationupstream of occluded segment 14 and the proximal end portion of thegraft could be positioned within blood vessel 11 at a locationdownstream of occluded segment 14 while the body portion of the graftcould be positioned substantially adjacent and outside of blood vessel11. Of course, an area within the blood vessel near each end portion ofthe graft could be isolated from fluid communication with the rest ofthe area within the blood vessel in a manner substantially similar tothat hereinbefore described with respect to upstream isolated region 40.After being advanced out the distal end of the catheter, the graft(including each outwardly extending end portion) could revert back toits prerolled configuration as hereinbefore described with respect tograft 60. Thereafter, a stent could be placed, in an expandedconfiguration, adjacent each of the end portions of the graft withinblood vessel 11 in order to secure such end portions of the graft toblood vessel 11 as hereinbefore described with respect to stent 90 andend portion 62 of graft 60.

What I claim is:
 1. A method of securing an end portion of a graft to ablood vessel of a patient's circulatory system during a bypass graftingprocedure, comprising the steps of:inhibiting blood flow to a region ofthe circulatory system by inflating a plurality of balloons within thecirculatory system, wherein a segment of the blood vessel is located inthe region; anastomosing the end portion of the graft to the segment ofthe blood vessel during the blood flow inhibiting step; and creating anarteriotomy in a sidewall of the segment of the blood vessel while (i)all of the plurality of balloons are inflated within the circulatorysystem, and (ii) prior to the anastomosing step.
 2. The method of claim1, wherein the anastomosing step and the arteriotomy creating step areeach performed while the segment of the blood vessel is covered by asubstantially intact portion of the epidermis of the body.
 3. A methodof securing an end portion of a graft to a blood vessel of a patient'scirculatory system during a bypass grafting procedure, comprising thesteps of:inhibiting blood flow to a region of the circulatory system byinflating a plurality of balloons within the circulatory system, whereina segment of the blood vessel is located in the region; and anastomosingthe end portion of the graft to the segment of the blood vessel duringthe blood flow inhibiting step, wherein the blood vessel is an aorta,wherein the blood flow inhibiting step includes the step of inflating afirst balloon of the plurality of balloons within the aorta to occludeblood flow at a first location in the aorta, wherein the blood flowinhibiting step further includes the step of inflating a second balloonof the plurality of balloons within the aorta to occlude blood flow at asecond location in the aorta, wherein the first location is spaced apartfrom the second location, and further comprising the step creating anarteriotomy in a sidewall of the segment of the aorta between the firstlocation and the second location while (i) all of the plurality ofballoons are inflated within the circulatory system, and (ii) prior tothe anastomosing step.
 4. A method of securing an end portion of a graftto a blood vessel of a patient's circulatory system during a bypassgrafting procedure, comprising the steps of:inhibiting blood flow to aregion of the circulatory system by inflating a plurality of balloonswithin the circulatory system, wherein a segment of the blood vessel islocated in the region; and anastomosing the end portion of the graft tothe segment of the blood vessel during the blood flow inhibiting step,wherein the blood flow inhibiting step includes the step of inflating afirst balloon of the plurality of balloons within the blood vessel toocclude blood flow at a first location in the blood vessel, wherein theblood flow inhibiting step further includes the step of inflating asecond balloon of the plurality of balloons within the blood vessel toocclude blood flow at a second location in the blood vessel, wherein thefirst location is spaced apart from the second location, and furthercomprising the step of creating an arteriotomy in a sidewall of thesegment of the blood vessel between the first location and the secondlocation while (i) all of the plurality of balloons are inflated withinthe circulatory system, and (ii) prior to the anastomosing step.
 5. Amethod of securing an end portion of a graft to a blood vessel of apatient's circulatory system during a bypass grafting procedure,comprising the steps of:inhibiting blood flow to a region of thecirculatory system by inflating a plurality of balloons within thecirculatory system, wherein a segment of the blood vessel is located inthe region; and anastomosing the end portion of the graft to the segmentof the blood vessel during the blood flow inhibiting step, wherein (i) afirst balloon of the plurality of balloons is included on a first distalportion of a first catheter, and (ii) a second balloon of the pluralityof balloons is included on a second distal portion of a second catheter,and further comprising the step of: advancing the first catheter and thesecond catheter within the circulatory system so as to position thefirst balloon and the second balloon within the circulatory system priorto the blood flow inhibiting step.
 6. A method of securing an endportion of a graft to a blood vessel of a patient's circulatory systemduring a bypass grafting procedure, comprising the steps of:inflating aplurality of balloons within the circulatory system to prevent bloodflow through a region of the circulatory system which includes a segmentof the blood vessel; anastomosing the end portion of the graft to thesegment of the blood vessel while the plurality of balloons are inflatedwithin the circulatory system; and creating an arteriotomy in a sidewallof the segment of the blood vessel while (i) all of the plurality ofballoons are inflated within the circulatory system, and (ii) prior tothe anastomosing step.
 7. The method of claim 6, wherein theanastomosing step and the arteriotomy creating step are each performedwhile the segment of the blood vessel is covered by a substantiallyintact portion of the epidermis of the body.
 8. A method of securing anend portion of a graft to a blood vessel of a patient's circulatorysystem during a bypass grafting procedure, comprising the stepsof:inflating a plurality of balloons within the circulatory system toprevent blood flow through a region of the circulatory system whichincludes a segment of the blood vessel; and anastomosing the end portionof the graft to the segment of the blood vessel while the plurality ofballoons are inflated within the circulatory system wherein the bloodvessel is an aorta, wherein the inflating step includes the step ofinflating a first balloon of the plurality of balloons within the aortato occlude blood flow at a first location in the aorta, wherein theinflating step further includes the step of inflating a second balloonof the plurality of balloons within the aorta to occlude blood flow at asecond location in the aorta, wherein the first location is spaced apartfrom the second location, and further comprising the step of creating anarteriotomy in a sidewall of the segment of the aorta between the firstlocation and the second location while (i) all of the plurality ofballoons are inflated within the circulatory system, and (ii) prior tothe anastomosing step.
 9. A method of securing an end portion of a graftto a blood vessel of a patient's circulatory system during a bypassgrafting procedure, comprising the steps of:inflating a plurality ofballoons within the circulatory system to prevent blood flow through aregion of the circulatory system which includes a segment of the bloodvessel; and anastomosing the end portion of the graft to the segment ofthe blood vessel while the plurality of balloons are inflated within thecirculatory system, wherein the inflating step includes the step ofinflating a first balloon of the plurality of balloons within the bloodvessel to occlude blood flow at a first location in the blood vessel,wherein the inflating step further includes the step of inflating asecond balloon of the plurality of balloons within the blood vessel toocclude blood flow at a second location in the blood vessel, wherein thefirst location is spaced apart from the second location, and furthercomprising the step of creating an arteriotomy in a sidewall of thesegment of the blood vessel between the first location and the secondlocation while (i) all of the plurality of balloons are inflated withinthe circulatory system, and (ii) prior to the anastomosing step.
 10. Amethod of securing an end portion of a graft to a blood vessel of apatient's circulatory system during a bypass grafting procedure,comprising the steps of:inflating a plurality of balloons within thecirculatory system to prevent blood flow through a region of thecirculatory system which includes a segment of the blood vessel; andanastomosing the end portion of the graft to the segment of the bloodvessel while the plurality of balloons are inflated within thecirculatory system, wherein (i) a first balloon of the plurality ofballoons is included on a first distal portion of a first catheter, and(ii) a second balloon of the plurality of balloons is included on asecond distal portion of a second catheter, and further comprising thestep of: advancing the first catheter and the second catheter within thecirculatory system so as to position the first balloon and the secondballoon within the circulatory system prior to the inflating step.
 11. Amethod of implanting an end portion of a graft within a patient's bodyduring a bypass grafting procedure, with the body including acirculatory system, comprising the steps of:isolating a region of thearea within the circulatory system from fluid communication with therest of the area within the circulatory system to inhibit blood flowthrough a segment of a blood vessel located within the region, whereinthe isolating step includes the step of inflating a plurality ofballoons within the circulatory system to occlude blood flow within thecirculatory system; and anastomosing the end portion of the graft to thesegment of the blood vessel during the isolating step; and creating anarteriotomy in a sidewall of the segment of the blood vessel while (i)all of the plurality of balloons are inflated within the circulatorysystem, and (ii) prior to the anastomosing step.
 12. The method of claim11, wherein the anastomosing step and the arteriotomy creating step areeach performed while the segment of the blood vessel is covered by asubstantially intact portion of the epidermis of the body.
 13. A methodof implanting an end portion of a graft within a patient's body during abypass grafting procedure, with the body including a circulatory system,comprising the steps of:isolating a region of the area within thecirculatory system from fluid communication with the rest of the areawithin the circulatory system to inhibit blood flow through a segment ofa blood vessel located within the region, wherein the isolating stepincludes the step of inflating a plurality of balloons within thecirculatory system to occlude blood flow within the circulatory system;and anastomosing the end portion of the graft to the segment of theblood vessel during the isolating step, wherein the blood vessel is anaorta, wherein the inflating step includes the step of inflating a firstballoon of the plurality of balloons within the aorta to occlude bloodflow at a first location in the aorta, wherein the inflating stepfurther includes the step of inflating a second balloon of the pluralityof balloons within the aorta to occlude blood flow at a second locationin the aorta, wherein the first location is spaced apart from the secondlocation, and further comprising the step of creating an arteriotomy ina sidewall of the segment of the aorta between the first location andthe second location while (i) all of the plurality of balloons areinflated within the circulatory system, and (ii) prior to theanastomosing step.
 14. A method of implanting an end portion of a graftwithin a patient's body during a bypass grafting procedure, with thebody including a circulatory system, comprising the steps of:isolating aregion of the area within the circulatory system from fluidcommunication with the rest of the area within the circulatory system toinhibit blood flow through a segment of a blood vessel located withinthe region, wherein the isolating step includes the step of inflating aplurality of balloons within the circulatory system to occlude bloodflow within the circulatory system; and anastomosing the end portion ofthe graft to the segment of the blood vessel during the isolating step,wherein the inflating step includes the step of inflating a firstballoon of the plurality of balloons within the blood vessel to occludeblood flow at a first location in the blood vessel, wherein theinflating step further includes the step of inflating a second balloonof the plurality of balloons within the blood vessel to occlude bloodflow at a second location in the blood vessel, wherein the firstlocation is spaced apart from the second location, and furthercomprising the step of creating an arteriotomy in a sidewall of thesegment of the blood vessel between the first location and the secondlocation while (i) all of the plurality of balloons are inflated withinthe circulatory system, and (ii) prior to the anastomosing step.
 15. Amethod of implanting an end portion of a graft within a patient's bodyduring a bypass grafting procedure, with the body including acirculatory system, comprising the steps of:isolating a region of thearea within the circulatory system from fluid communication with therest of the area within the circulatory system to inhibit blood flowthrough a segment of a blood vessel located within the region, whereinthe isolating step includes the step of inflating a plurality ofballoons within the circulatory system to occlude blood flow within thecirculatory system; and anastomosing the end portion of the graft to thesegment of the blood vessel during the isolating step, wherein (i) afirst balloon of the plurality of balloons is included on a first distalportion of a first catheter, and (ii) a second balloon of the pluralityof balloons is included on a second distal portion of a second catheter,and further comprising the step of: advancing the first catheter and thesecond catheter within the circulatory system so as to position thefirst balloon and the second balloon within the circulatory system priorto the isolating step.
 16. A method of securing an end portion of agraft to a blood vessel of a patient's circulatory system during abypass grafting procedure, comprising the steps of:preventing blood flowthrough a region of the circulatory system which includes a segment ofthe blood vessel by inflating a plurality of balloons within thecirculatory system; anastomosing the end portion of the graft to thesegment of the blood vessel during the blood flow preventing step; andcreating an arteriotomy in a sidewall of the segment of the blood vesselwhile (i) all of the plurality of balloons are inflated within thecirculatory system, and (ii) prior to the anastomosing step.
 17. Themethod of claim 16, wherein the anastomosing step and the arteriotomycreating step are each performed while the segment of the blood vesselis covered by a substantially intact portion of the epidermis of thebody.
 18. A method of securing an end portion of a graft to a bloodvessel of a patient's circulatory system during a bypass graftingprocedure, comprising the steps of:preventing blood flow through aregion of the circulatory system which includes a segment of the bloodvessel by inflating a plurality of balloons within the circulatorysystem; and anastomosing the end portion of the graft to the segment ofthe blood vessel during the blood flow preventing step, wherein theblood vessel is an aorta, and wherein the blood flow preventing stepincludes the step of inflating a first balloon of the plurality ofballoons within the aorta to occlude blood flow at a first location inthe aorta, wherein the blood flow preventing step further includes thestep of inflating a second balloon of the plurality of balloons withinthe aorta to occlude blood flow at a second location in the aorta,wherein the first location is spaced apart from the second location, andfurther comprising the step of creating an arteriotomy in a sidewall ofthe segment of the aorta between the first location and the secondlocation while (i) all of the plurality of balloons are inflated withinthe circulatory system, and (ii) prior to the anastomosing step.
 19. Amethod of securing an end portion of a graft to a blood vessel of apatient's circulatory system during a bypass grafting procedure,comprising the steps of:preventing blood flow through a region of thecirculatory system which includes a segment of the blood vessel byinflating a plurality of balloons within the circulatory system; andanastomosing the end portion of the graft to the segment of the bloodvessel during the blood flow preventing step, wherein the blood flowpreventing step includes the step of inflating a first balloon of theplurality of balloons within the blood vessel to occlude blood flow at afirst location in the blood vessel, wherein the blood flow preventingstep further includes the step of inflating a second balloon of theplurality of balloons within the blood vessel to occlude blood flow at asecond location in the blood vessel, wherein the first location isspaced apart from the second location, and further comprising the stepof creating an arteriotomy in a sidewall of the segment of the bloodvessel between the first location and the second location while (i) allof the plurality of balloons are inflated within the circulatory system,and (ii) prior to the anastomosing step.
 20. A method of securing an endportion of a graft to a blood vessel of a patient's circulatory systemduring a bypass grafting procedure, comprising the steps of:preventingblood flow through a region of the circulatory system which includes asegment of the blood vessel by inflating a plurality of balloons withinthe circulatory system; and anastomosing the end portion of the graft tothe segment of the blood vessel during the blood flow preventing step,wherein (i) a first balloon of the plurality of balloons is included ona first distal portion of a first catheter, and (ii) a second balloon ofthe plurality of balloons is included on a second distal portion of asecond catheter, and further comprising the step of: advancing the firstcatheter and the second catheter within the circulatory system so as toposition the first balloon and the second balloon within the circulatorysystem prior to the blood flow preventing step.
 21. A method of securingan end portion of a graft to a blood vessel, comprising the stepsof:inflating a balloon within the blood vessel so that the balloonpartitions the blood vessel into a first vessel segment of the bloodvessel and a second vessel segment of the blood vessel, wherein a flowof blood within the first vessel segment is prevented from advancing tothe second vessel segment while the balloon is inflated within the bloodvessel; anastomosing the end portion of the graft to the second vesselsegment while the balloon is inflated within the blood vessel; andcreating an arteriotomy in a sidewall of the second vessel segment while(i) the balloon is inflated within the circulatory system, and (ii)prior to the anastomosing step.
 22. The method of claim 21, wherein theanastomosing step and the arteriotomy creating step are each performedwhile the second vessel segment is covered by a substantially intactportion of the epidermis of the body.
 23. A method of securing an endportion of a graft to a blood vessel of a circulatory system, comprisingthe steps of:inflating a balloon within the circulatory system so thatthe balloon partitions the circulatory system into a first circulatoryregion and a second circulatory region, wherein a flow of blood withinthe first circulatory region is prevented from advancing to the secondcirculatory region while the balloon is inflated within the circulatorysystem; anastomosing the end portion of the graft to the blood vesselwhile the balloon is inflated within the circulatory system, wherein theblood vessel is located within the second circulatory region; andcreating an arteriotomy in a sidewall of a segment of the blood vesselwhile (i) the balloon is inflated within the circulatory system, and(ii) prior to the anastomosing step.
 24. The method of claim 23, whereinthe anastomosing step and the arteriotomy creating step are eachperformed while the segment of the blood vessel is covered by asubstantially intact portion of the epidermis of the body.
 25. A methodof securing an end portion of a graft to a circulatory system,comprising the steps of:inflating a balloon within the circulatorysystem so that the balloon partitions the circulatory system into afirst circulatory region and a second circulatory region, wherein a flowof blood within the first circulatory region is prevented from advancingto the second circulatory region while the balloon is inflated withinthe circulatory system; creating an arteriotomy in a sidewall of asegment of a blood vessel located within the second circulatory regionwhile the balloon is inflated within the circulatory system; andanastomosing the end portion of the graft to the segment of the bloodvessel while the balloon is inflated within the circulatory system.wherein the anastomosing step and the arteriotomy creating step are eachperformed while the segment of the blood vessel is covered by asubstantially intact portion of the epidermis of the body.
 26. A methodof securing an end portion of a graft to a blood vessel of a circulatorysystem, comprising the steps of:inflating a balloon within thecirculatory system so that the balloon creates a partition between afirst circulatory region and a second circulatory region, wherein a flowof blood within the first circulatory region is inhibited from advancingto the second circulatory region while the balloon is inflated withinthe circulatory system; anastomosing the end portion of the graft to theblood vessel while the balloon is inflated within the circulatorysystem, wherein the blood vessel is located within the secondcirculatory region; and creating an arteriotomy in a sidewall of asegment of the blood vessel while (i) the balloon is inflated within thecirculatory system, and (ii) prior to the anastomosing step.
 27. Themethod of claim 26, wherein the anastomosing step and the arteriotomycreating step are each performed while the segment of the blood vesselis covered by a substantially intact portion of the epidermis of thebody.